A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients with Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) with No Distant Metastases

The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab.
Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm).
The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.

Start Date01 Nov 2024

Sponsor / Collaborator

Rakuten Medical, Inc.

JPRN-jRCT2041230050 / RecruitingPhase 4IIT

An Uncontrolled, Open-label, Multicenter Safety Confirmation Study of 5 or More Cycles of Photoimmunotherapy with Cetuximab Sarotalocan Sodium (Genetical Recombination) in Patients with Unresectable, Locally Advanced or Locally Recurrent Head and Neck Cancer

Start Date25 Jun 2023

Sponsor / Collaborator-

NCT05265013 / TerminatedPhase 2

A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment

Start Date19 Apr 2022

Sponsor / Collaborator

Rakuten Medical, Inc.

100 Clinical Results associated with Cetuximab Sarotalocan Sodium (Genetical Recombination)

100 Translational Medicine associated with Cetuximab Sarotalocan Sodium (Genetical Recombination)

100 Patents (Medical) associated with Cetuximab Sarotalocan Sodium (Genetical Recombination)

Literatures (Medical) associated with Cetuximab Sarotalocan Sodium (Genetical Recombination)

25 Jan 2024·Investigative ophthalmology & visual science

Tumor Pigmentation Does Not Affect Light-Activated Belzupacap Sarotalocan Treatment but Influences Macrophage Polarization in a Murine Melanoma Model

Article

Author: Rich, Cadmus ; Mulder, Aat A. ; Hao, Yang ; van Hall, Thorbald ; Gu, Zili ; Ossendorp, Ferry A. ; van Veelen, Peter A. ; Huis in't Veld, Ruben V. ; Vu, T. Khanh H. ; Jager, Martine J. ; Ma, Sen ; Gelmi, Maria Chiara

Purpose:

Pigmentation in uveal melanoma is associated with increased malignancy and is known as a barrier for photodynamic therapy. We investigated the role of pigmentation in tumor behavior and the response to light-activated Belzupacap sarotalocan (Bel-sar) treatment in a pigmented (wild type) and nonpigmented (tyrosinase knock-out [TYR knock-out]) cell line in vitro and in a murine model.

Methods:

The B16F10 (TYR knock-out) was developed using CRISPR/Cas9. After the treatment with light-activated Bel-sar, cytotoxicity and exposure of damage-associated molecular patterns (DAMPs) were measured by flow cytometry. Treated tumor cells were co-cultured with bone marrow-derived macrophages (BMDMs) and dendritic cells (DCs) to assess phagocytosis and activation. Both cell lines were injected subcutaneously in syngeneic C57BL/6 mice.

Results:

Knock-out of the tyrosinase gene in B16F10 led to loss of pigmentation and immature melanosomes. Pigmented tumors contained more M1 and fewer M2 macrophages compared with amelanotic tumors. Bel-sar treatment induced near complete cell death, accompanied with enhanced exposure of DAMPs in both cell lines, resulting in enhanced phagocytosis of BMDMs and maturation of DCs. Bel-sar treatment induced a shift to M1 macrophages and delayed tumor growth in both in vivo tumor models. Following treatment, especially the pigmented tumors and their draining lymph nodes contained IFN-gamma positive CD8+T cells.

Conclusions:

Pigmentation influenced the type of infiltrating macrophages in the tumor, with more M1 macrophages in pigmented tumors. Belzupacap sarotalocan treatment induced immunogenic cell death and tumor growth delay in pigmented as well as in nonpigmented models and stimulated M1 macrophage influx in both models.

01 Dec 2023·Cancer science

Near‐infrared photoimmunotherapy in the models of hepatocellular carcinomas using cetuximab‐IR700

Article

Author: Kato, Takuya ; Takao, Seiichiro ; Choyke, Peter L ; Kobayashi, Hisataka ; Fukushima, Hiroshi ; Escorcia, Freddy E ; Furusawa, Aki ; King, A Paden ; Okuyama, Shuhei ; Kano, Makoto

Abstract:

Epidermal growth factor receptor (EGFR) has emerged as an important therapeutic target in many cancers, and overexpression of EGFR is frequently observed in hepatocellular carcinomas (HCCs). Near‐infrared photoimmunotherapy (NIR‐PIT) is a new anticancer treatment that selectively damages the cell membrane of cancer cells after NIR light‐induced photochemical reaction of IR700, which is bound to a targeting antibody on the cell membrane. NIR‐PIT using cetuximab‐IR700 has already been approved in Japan, is under review by the US Food and Drug Administration (FDA) for advanced head and neck cancers, and its safety has been established. However, EGFR has not been investigated as a target in NIR‐PIT in HCCs. Here, we investigate the application of NIR‐PIT using cetuximab‐IR700 to HCCs using xenograft mouse models of EGFR‐expressing HCC cell lines, Hep3B, HuH‐7, and SNU‐449. In vitro NIR‐PIT using EGFR‐targeted cetuximab‐IR700 killed cells in a NIR light dose‐dependent manner. In vivo NIR‐PIT resulted in a delayed growth compared with untreated controls. In addition, in vivo NIR‐PIT in both models showed histological signs of cancer cell damage, such as cytoplasmic vacuolation and nuclear dysmorphism. A significant decrease in Ki‐67 positivity was also observed after NIR‐PIT, indicating decreased cancer cell proliferation. This study suggests that NIR‐PIT using cetuximab‐IR700 has potential for the treatment of EGFR‐expressing HCCs.

01 Aug 2023·Auris, nasus, larynx

Transnasal photoimmunotherapy with cetuximab sarotalocan sodium: Outcomes on the local recurrence of nasopharyngeal squamous cell carcinoma

Author: Yokoyama, Kazuki ; Omura, Go ; Honma, Yoshitaka ; Yoshimoto, Seiichi ; Eguchi, Kohtaro ; Ohara, Akihiro ; Itoyama, Mai ; Kato, Ken ; Matsumoto, Yoshifumi ; Watanabe, Takane ; Sakai, Toshihiko ; Shinozaki, Takeshi

Photoimmunotherapy for head and neck cancer (HNC-PIT) is a newly developed locoregional treatment targeting the epidermal growth factor. This treatment consists in administering cetuximab sarotalocan sodium that conjugates cetuximab with the dye IRdye700DX, which is activated by near-infrared ray illumination at 690 nm. HNC-PIT has been conditionally approved in Japan in September 2020 for the treatment of unresectable locally advanced or unresectable locoregionally recurrent HNC. However, its outcomes on the local recurrence of the nasopharyngeal squamous cell carcinoma (NPSCC) remain undetermined. In this report, we assessed the effects of HNC-PIT assisted by transnasal endoscopy on the local recurrence of NPSCC. A 77-year-old male presented with a local recurrence of NPSCC. The initial diagnosis revealed a squamous cell carcinoma, T2N2M0 stage III, positive for Epstein-Barr virus-encoded small RNA by in situ hybridization, which was treated with concurrent chemoradiotherapy (CRT). However, local recurrence was detected 14 months after CRT. We performed HNC-PIT under transnasal endoscopy. Seven months have passed since the HNC-PIT treatment, and the patient is alive without delayed adverse events and evidence of recurrence. Local recurrence of NPSCC, which is difficult to treat with minimally invasive surgery, is considered a potential candidate for HNC-PIT.

News (Medical) associated with Cetuximab Sarotalocan Sodium (Genetical Recombination)

19 Aug 2024

·www.prnewswire.com

Rakuten Medical Announces New Management Team to Drive the Next Phase of Growth and Innovation

Mickey Mikitani, as sole CEO, reaffirms his commitment to the company's mission of conquering cancer for patients all over the world Minami Maeda has been appointed as the new President to expedite pipeline development, with a strategic focus on securing FDA approval for ASP-1929, expanding into broader Asia, and further driving commercial growth in Japan A new global Phase 3 clinical trial for ASP-1929 photoimmunotherapy in combination with anti-PD-1 is expected to be initiated in 2H 2024 SAN DIEGO, Aug. 19, 2024 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing oncology precision, cell-targeting photoimmunotherapy through its proprietary Alluminox™ platform, announces that Hiroshi "Mickey" Mikitani now serves as its sole Chief Executive Officer and Vice Chairman of the Board, and Minami Maeda has been appointed as its new President, effective August 9, 2024. Takashi "Tora" Toraishi has chosen to step down from his role as Co-Chief Executive Officer, President and Board Director. The new management team is set to further advance Rakuten Medical's Alluminox™ platform and prioritize obtaining FDA approval for ASP-1929 as early as possible. The company's new global Phase 3 study of ASP-1929 photoimmunotherapy in combination with anti-PD-1 for first-line recurrent head and neck squamous cell carcinoma (HNSCC) is expected to commence first in the United States in 2H 2024. Rakuten Medical also aims to extend its reach into Asian markets, where many countries face high unmet medical needs, by leveraging its growing expertise from commercial treatments in Japan. Asia accounts for half of the world's cancer incidence and has the highest cancer mortality rate*. Rakuten Medical's strong track record of commercial success in Japan has generated substantial scientific publications, which the company believes would help support new medical communities' better understanding of the Alluminox™ platform. In Japan, the company will continue to drive growth and vigorously support the realization of its strategic agenda in the U.S. and Asia. Mickey Mikitani, Chief Executive Officer and Vice Chairman of the Board of Rakuten Medical, stated, "The appointment of Minami as President and the formation of our new management team underscores our unwavering commitment to advancing our innovation for patients in need. We continue striving to advance cancer treatment through our technology platform, and I am fully committed to further driving the company's vision and strategic direction." "I am honored to take on this pivotal role at such a critical time for Rakuten Medical," said Minami Maeda, President of Rakuten Medical. "Our treatment has positively impacted patients' lives in Japan, as demonstrated by our robust commercial growth there. I am excited to collaborate with our talented team to build an even stronger company and extend our contributions to more patients and broader communities as we continue to pursue our global development efforts." Since joining Rakuten Medical in November 2017, Maeda has demonstrated outstanding leadership and strategic acumen. Most recently serving as Chief Commercial Officer of Rakuten Medical, Inc., and Representative Director & President of Rakuten Medical K.K., he has significantly contributed to commercial growth and established a scalable business model for the company's innovative drug-device combination in Japan. His efforts have greatly enhanced the company's global growth and technological advancements. Prior to his tenure at Rakuten Medical, Maeda gained extensive experience in business and public policy through his work at McKinsey & Company's Tokyo and Johannesburg offices. He also served as Chief of Staff to Japan's Minister of Health, Labor, and Welfare. Rakuten Medical extends its gratitude to Toraishi for his strong leadership and contributions since 2017. His tenure has been marked by significant achievements, including the successful development and the world-first approval of ASP-1929 in Japan, and the establishment of a strong foundation for future growth. Disclaimer: Rakuten Medical's therapies based on Alluminox™ platform are investigational outside of Japan. * Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing and tumor necrosis. Alluminox therapies have not yet been approved outside of Japan. Rakuten Medical is committed to its mission to conquer cancer by delivering its innovative treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit . About Alluminox™ platform The Alluminox™ platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Alluminox platform as a technology consisting of a drug, device, and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the targeted cells with light to transiently activate the drug. Pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cancer cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Outside of Japan, Alluminox therapies have not yet been approved by any regulatory authority. Forward Looking Statements This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the anticipated results and expectations expressed in these statements. These "forward looking statements" contain information about the status and development of our products, including the Alluminox™ platform, as well as other regulatory and marketing authorization efforts, the potential benefits, efficacy, and safety of therapies created using the Alluminox platform, and the status of regulatory filings. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of our therapies, and the status of regulatory filings. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "strategy," "will," and "do", and are based on our current beliefs. In addition, this press release uses terms such as "important," "notable," and "abnormal" to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of our therapies, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of our therapies, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements. Contact Us SOURCE Rakuten Medical, Inc.

Executive ChangeImmunotherapyPhase 3Drug Approval

29 May 2024

·www.biospace.com

Rakuten Medical to Host R&D Day Highlighting Recent Interim Data from Phase 1b/2 Clinical Trial of ASP-1929 Photoimmunotherapy in Combination with anti-PD-1 in r/m HNSCC

Dr. Gillenwater will review the updated safety and efficacy findings which will be presented at ASCO 2024 Rakuten Medical's management team will provide recent clinical and business updates The event will be held virtually on Thursday, June 20, 2024, at 1:00 pm ET / 10:00 am PT SAN DIEGO, May 29, 2024 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox™ platform, today announced that it will host a virtual R&D Day on Thursday, June 20, 2024 at 1:00 pm ET / 10:00 am PT. The event will feature a key opinion leader, Dr. Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, who will discuss the updated safety and efficacy findings from an interim evaluation of Rakuten Medical's open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 therapy in first line recurrent and/or metastatic head and neck squamous cell carcinoma, which will be presented in a poster at ASCO 2024. Rakuten Medical's executive management team will provide other key clinical and business updates including, but not limited to, development programs including a new study and Japan commercial updates. A live question and answer session will follow the formal presentation. Please note that practicing healthcare professionals and patients are not permitted to attend. R&D Day event site: R&D Day event site: About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing and tumor necrosis. Alluminox therapies have not yet been approved outside of Japan. Rakuten Medical is committed to its mission to conquer cancer by delivering our innovative treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 6 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, Switzerland and India. For more information, visit . About Alluminox™ platform The Alluminox™ platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Alluminox platform as a technology consisting of a drug, device, and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the targeted cells with light to transiently activate the drug. Pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cancer cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Outside of Japan, Alluminox therapies have not yet been approved by any regulatory authority. Forward Looking Statements This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the anticipated results and expectations expressed in these statements. These "forward looking statements" contain information about the status and development of our products, including the Alluminox™ platform, as well as other regulatory and marketing authorization efforts, the potential benefits, efficacy, and safety of therapies created using the Alluminox platform, and the status of regulatory filings. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of our therapies, and the status of regulatory filings. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "strategy," "will," and "do", and are based on our current beliefs. In addition, this press release uses terms such as "important," "notable," and "abnormal" to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of our therapies, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of our therapies, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements. Contact Us

ImmunotherapyClinical Study

28 May 2024

·www.pharmaceutical-technology.com

ASCO 2024: Rakuten’s photoimmunotherapy and Keytruda combo shows efficacy in HNSCC

Rakuten’s lead therapy, ASP-1929, is an antibody-dye conjugate comprising of an epidermal growth factor receptor (EGFR) antagonist antibody, cetuximab, and a light activatable dye, IRDue 700DX. Image Credit: Poetra.RH / Shutterstock. US-based Rakuten Medical has announced positive interim data from the Phase Ib/II trial of its photoimmunotherapy, ASP-1929, in combination with Merck & Co (MSD)’s Keytruda (pembrolizumab) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). Following the positive results, the company now plans to start a global Phase III clinical trial evaluating the combination therapy of ASP-1929 and Keytruda as first-line therapy in recurrent HNSCC in the second half of this year. The study’s primary endpoint will be overall survival. The results from the open-label Phase Ib/II study (NCT04305795) will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from 31 May to 4 June. ASP-1929 is an antibody-dye conjugate comprising of an epidermal growth factor receptor (EGFR) antagonist antibody, cetuximab, and a light-activated dye, IRDue 700DX. The therapy is activated locally by inducing a photochemical reaction when illuminated with red light using a laser device system. This potentially causes membrane damage in cancer cells, leading to selective necrosis of cancer cells. Cetuximab is independently sold under the brand name Erbitux by Bristol Myers Squibb as a treatment for late-stage HNSCC and metastatic colorectal cancer . See Also: South Korea’s MFDS approves Eisai-Biogen’s LEQEMBI for Alzheimer’s ASCO 2024: MediLink’s NSCLC and breast cancer ADC shows early safety success ASP-1929 received fast track designation from the US Food and Drug Administration (FDA) in 2018. It was approved as a treatment for unresectable locally advanced or recurrent head and neck cancer in Japan. As of the data cut-off of 31 August 2023, 18 out of 19 patients received both therapies in the Phase Ib/II trial. Median overall survival and duration of response were not reached as of the data cut-off. The therapy had an objective response rate (ORR) of 35.3%, with four complete and two partial responses. At 24 months, the treatment had an estimated survival rate of 52.4%. Commonly observed serious adverse reactions included dysphagia and tongue oedema. While there were no fatal events, two Grade 4 events, namely laryngeal oedema and tumour haemorrhage, were observed due to advanced disease. In March, Rakuten raised $119m in a Series E financing round to develop its Alluminox drug discovery platform and fund the Phase III ASP-1929 monotherapy trial (NCT03769506). The open-label Phase III study is expected to enrol approximately 275 participants with recurrent HNSCC who have received at least two prior lines of therapy.

Phase 3Fast TrackImmunotherapyClinical ResultASCO

100 Deals associated with Cetuximab Sarotalocan Sodium (Genetical Recombination)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Head and Neck Neoplasms	JP	Rakuten Medical, Inc.	25 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Head and Neck Carcinoma	Phase 3	US	Rakuten Medical, Inc.	09 May 2019
Recurrent Head and Neck Carcinoma	Phase 3	JP	Rakuten Medical, Inc.	09 May 2019
Recurrent Head and Neck Carcinoma	Phase 3	IN	Rakuten Medical, Inc.	09 May 2019
Recurrent Head and Neck Carcinoma	Phase 3	TW	Rakuten Medical, Inc.	09 May 2019
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	US	Rakuten Medical, Inc.	09 May 2019
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	JP	Rakuten Medical, Inc.	09 May 2019
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	IN	Rakuten Medical, Inc.	09 May 2019
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	TW	Rakuten Medical, Inc.	09 May 2019
Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck	Phase 2	US	Rakuten Medical, Inc.	21 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 2	US	Rakuten Medical, Inc.	21 Dec 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	30	cetuximab sarotalocan	pdfhjkbnvk(wtjhdkhtaz) = ztswrncbis rrjvufxfte (rreqkbwsxy ) View more	Positive	05 Oct 2024
NCT04305795 (ASP-1929-181, ASCO2024) Manual	Phase 1/2	Advanced Head and Neck Squamous Cell Carcinoma EGFR Positive	19	ASP-1929 PIT+pembrolizumab	cgrdkemstb(smhcrqmxdl) = ymnyiinweo agfdocwhkf (kbszuzyehc, 13.3 - 59.0) View more	Positive	25 May 2024
NCT04305795 (ASP-1929-181, AHNS2023)	Phase 1/2	Advanced Head and Neck Squamous Cell Carcinoma EGFR-expressing	26	ASP-1929 photoimmunotherapy	xtqmodnfco(jfdlrkkihr) = veuqrhlltg sjlsxkxrkg (mkevwiwxbd, 10.3 - 56.0) View more	Positive	10 Jul 2023
RM-1929-102 (PMDA) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck	3	Akalux 640mg/m2 + Radiotherapy	uojjvzmgvp(gexqanesli) = zmvqnhgbus npxpvsuxru (rcuqiroqle ) View more	Positive	25 Sep 2020
Biospace Manual	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck	30	Cetuximab Sarotalocan Sodium	aylukokjau(ilrcnsdyyc) = bbumsnfddu wdlzniyzvq (gnuewwjcfo, 2.1 - 5.5) View more	Positive	01 Jun 2019

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